(70 days)
P810005, P820086
P810005,P820086
No
The document describes a standard soft contact lens with no mention of AI or ML technology in its design, function, or testing.
No.
The device is indicated for optical correction of refractive ametropia (myopia, hyperopia, and astigmatism), which is a corrective function, not a therapeutic one.
No
Explanation: The device, SEE3™ (lotrafilcon A) soft contact lenses, is indicated for the optical correction of refractive ametropia. It is a treatment device, not a diagnostic one.
No
The device description clearly indicates it is a physical contact lens made of a specific material (lotrafilcon A) with defined physical dimensions and properties. It is supplied as a sterile, packaged product. This is a hardware medical device, not software.
Based on the provided information, the SEE3™ (lotrafilcon A) soft contact lens is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or non aphakic persons with non-diseased eyes. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens designed to be worn on the eye for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This contact lens does not perform such tests.
N/A
Intended Use / Indications for Use
SEE3™ (lotrafilcon A) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or non aphakic persons with non-diseased eyes.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection and monthly replacement. SEE3™ (lotrafilcon A) lenses may be cleaned using a chemical, not heat, disinfection system.
Product codes
Not Found
Device Description
The SEE3™ (lotrafilcon A) soft contact lens is a new soft contact lens suiteble for daily wear. The lens material is 24% water and 76% lotrafilcon A, a silicone containing hydrogel treated with a plasma coating.
The SEE3™ (lotrafilcon A) contact lens is available in a spherical lens design of the following dimensions:
Chord Diameter: 14.0 mm
Center Thickness: 0.05 to 0.35 mm (varies with power)
Base Curve: 8.8 mm
Power Range: -20.00D to +20.00D
Powers Available: -5.00D to +5.00D (0.25D steps), -6.00, -5.50, +5.50, +6.00D
A clear lens has the following properties:
Specific gravity: 1.08
Refractive index: 1.43 (hydrated)
Light transmittance: 99 %
Water content : 24 % by weight in normal saline
Oxygen permeability : 140 x 10 [(cm2 /sec)(ml O2 /mlommHg)] measured at 35°C, Coulometric method.
Lenses are supplied sterile in sealed glass vials containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the glass vial packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Vial containers are labeled with the lens parameters. lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterlity). Stability study data currently supports a twelve (12) month shelf-life for the SEE3" (lotrafficon A) soft contact lons in sealed glass vials. Shelf-life studies are ongoing to determine extension of expiration dating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A series of nonclinical tests and clinical studies were performed to demonstrate the safety and effectiveness of the SEE3™ (lotrafilcon A) contact lens, and establish substantial equivalence to a currently marketed, predicate (control) lens. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and in conformance to applicable device regulations. Results demonstrate the lens is nontoxic and biocompatible, and has material characteristics comparable to or better than other currently marketed soft contact lenses. Clinically, the lens has performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses.
Nonclinical Testing: A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens. All nonclinical toxicology tests were conducted in accordance with the GLP regulation (21 CFR Part 58). The results of the nonclinical testing on the SEE3™ (lotrafilcon A) contact lens demonstrate that:
- The lens material and extracts are not toxic and non irritating.
- Lens physical and material properties are consistent with industry marketed lenses.
- The lens material remains unaffected, with respect to lens properties, by exposure to chemical cleaning and disinfection systems. The amount of preservatives in the tested care regimens show similar uptake and release profiles to the predicate device.
Clinical Testing: The SEE3™ (lotrafilcon A) contact lens was investigated in daily wear clinical study. The three month clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812). The study assessed the safety and effectiveness, and clinical performance as compared to a predicate control lens. Clinical evaluation of the SEE3™ (lotrafilcon A) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions.
Key Metrics
Not Found
Predicate Device(s)
P810005, P820086
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
CIBA Vision® Corporation 1460 Johns Creek Parkway Duluth. GA USA 30155
SEE3™ (lotrafilcon A) Soft Contact Lens 510(k) Summary of Safety and Substantial Equivalence
510(k) Summary K970 746
1. Submitter Information:
MAY - 9 1997
| Company: | CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, Georgia 30155-1518 |
|-----------------|------------------------------------------------------------------------------------|
| Contact Person: | Alicia M. Plesnarski, RAC
Senior Associate, Regulatory Affairs |
| Telephone: | 770-418-3924 |
| FAX: | 770-418-3033 |
| Date Prepared: | February 28, 1997 |
2. Device Name:
- Common Name: Soft Contact Lens ●
- SEE3™ (lotrafilcon A) . Trade/Proprietary Name:
- Classification Name: . Daily Wear Soft (hydrophilic) Contact Lens
- Device Classification: Class II {21 CFR 886.5925 (b) (1)} ●
3. Predicate Device:
The predicate lens was selected to address both intended use (daily wear) and material type (FDA Group I: low water, nonionic polymer):
- Cibasoft® (tefilcon), FDA Group 1, low water, nonionic soft contact . lenses for daily wear; CIBAVision® Corporation - PMAs P810005, P820086
Premarket Notification 510(k) : clear (lotrafilcon A) Soft Contact Lens Part IX. Summary of Safety & Substantial Equivalence, Rev. 00, 510SUM_0.DOC, Page 1 of 4
1
Image /page/1/Picture/2 description: The image shows the logo and address of CIBA Vision Corporation. The address is 11460 Johns Creek Parkway, Duluth, GA USA 30155. The image also mentions SEE3™ (lotrafilcon A) Soft Contact Lens and 510(k) Summary of Safety and Substantial Equivalence.
4. Description of Device:
The SEE3™ (lotrafilcon A) soft contact lens is a new soft contact lens suiteble for daily wear. The lens material is 24% water and 76% lotrafilcon A, a silicone containing hydrogel treated with a plasma coating.
The SEE3™ (lotrafilcon A) contact lens is available in a spherical lens design of the following dimensions:
Chord Diameter: | 14.0 mm |
---|---|
Center Thickness: | 0.05 to 0.35 mm (varies with power) |
Base Curve: | 8.8 mm |
Power Range: | -20.00D to +20.00D |
Powers Available: | -5.00D to +5.00D (0.25D steps), |
-6.00, -5.50, +5.50, +6.00D |
A clear lens has the following properties:
- Specific gravity: 1.08 . Refractive index: 1.43 (hydrated) . Light transmittance: . 2 99 % ● Water content : 24 % by weight in normal saline 140 x 10 *1 Oxvoen permeability .
[(cm2 /sec)(ml O2 /mlommHg)] measured at 35°C, Coulometric method.
Lenses are supplied sterile in sealed glass vials containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the glass vial packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Vial containers are labeled with the lens parameters. Iot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterlity). Stability study data currently supports a twelve (12) month shelf-life for the SEE3" (lotrafficon A) soft contact lons in sealed glass vials. Shelf-life studies are ongoing to determine extension of expiration dating.
5. Indications for Use:
SEE3™ (lotrafilcon A) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or non aphakic persons with non-diseased eyes.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection and monthly replacement. SEE3™ (lotrafilcon A) lenses may be cleaned using a chemical, not heat, disinfection system.
2
IBA Vision® Corporation 1460 Johns Creek Parkway Duluth, GA USA 30155
SEE3™ (lotrafilcon A) Soft Contact Lens
510(k) Summary of Safety and Substantial Equivalence
6. Description of Safety and Substantial Equivalence:
A series of nonclinical tests and clinical studies were performed to demonstrate the safety and effectiveness of the SEE3™ (lotrafilcon A) contact lens, and establish substantial equivalence to a currently marketed, predicate (control) lens. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and in conformance to applicable device regulations. Results demonstrate the lens is nontoxic and biocompatible, and has material characteristics comparable to or better than other currently marketed soft contact lenses. Clinically, the lens has performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses.
Nonclinical Testing:
A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens. All nonclinical toxicology tests were conducted in accordance with the GLP regulation (21 CFR Part 58).
The results of the nonclinical testing on the SEE3™ (lotrafilcon A) contact lens demonstrate that:
- The lens material and extracts are not toxic and non irritating. ◆
- Lens physical and material properties are consistent with industry . marketed lenses.
- The lens material remains unaffected, with respect to lens properties, by . exposure to chemical cleaning and disinfection systems. The amount of preservatives in the tested care regimens show similar uptake and release profiles to the predicate device.
Clinical Testing:
The SEE3™ (lotrafilcon A) contact lens was investigated in daily wear clinical study. The three month clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812). The study assessed the safety and effectiveness, and clinical performance as compared to a predicate control lens.
Clinical evaluation of the SEE3™ (lotrafilcon A) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions.
3
Image /page/3/Picture/0 description: The image shows a logo for CIBA Vision Corporation. The logo includes the company name and address: 11460 Johns Creek Parkway, Duluth, GA USA 30155. Below the company information, it states "SEE3™ (lotrafilcon A) Soft Contact Lens" and "510(k) Summary of Safety and Substantial Equivalence".
Substantial Equivalence:
The SEE3™ (lotrafilcon A) contact lens is similar to other daily wear soft contact lenses in terms of water content (24% water) and ionic characteristics (FDA Group I: low water, nonionic), clinical performance, and indications for use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen.
Any differences which may exist between the (lotrafilcon A) contact lens and other Group I soft hydrophilic plastic contact lenses does not adversely effect the safety and effectiveness of the device.